Expanded Access to Voxelotor for Patients With Sickle Cell Disease Who Have No Alternative Treatment Options
- Conditions
- Sickle Cell Disease
- Registration Number
- NCT03943615
- Lead Sponsor
- Pfizer
- Brief Summary
The intent of this open-label, multicenter expanded access program (EAP) is to provide early access to voxelotor prior to market authorization
- Detailed Description
The purpose of this program is to provide early access to voxelotor for patients with sickle cell disease who have exhausted alternative treatment options and are ineligible for actively-recruiting clinical trials of voxelotor.
This EAP may continue until such time that voxelotor is commercially available or the Sponsor discontinues the voxelotor EAP. Discontinuation may occur earlier if an individual participant or physician or Sponsor Medical Monitor decides to discontinue treatment.
Recruitment & Eligibility
- Status
- NO_LONGER_AVAILABLE
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Alabama Oncology
🇺🇸Birmingham, Alabama, United States
University of South Alabama
🇺🇸Mobile, Alabama, United States
Children's Healthcare of Atlanta
🇺🇸Atlanta, Georgia, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Our Lady of the Lake Physician Group
🇺🇸Baton Rouge, Louisiana, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
The John Hopkins Hospital
🇺🇸Baltimore, Maryland, United States
Rutgers Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
Montefiore Medical Center PRIME
🇺🇸Bronx, New York, United States
Queens Hospital Center
🇺🇸Jamaica, New York, United States
Scroll for more (8 remaining)Alabama Oncology🇺🇸Birmingham, Alabama, United States